An interventional study of trehalose in Spinocerebellar Ataxia 3, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment
There are no clinically established treatments which have been proven to delay the disease progression in spinocerebellar ataxia (SCA) 3. Most available treatments are only for symptom alleviation, and thus the majority of patients will eventually progress to needing and wheel chair and eventually bedridden.
As trehalose appear to be potentially promising treatment in SCA, the investigators aim to conduct this study using oral trehalose in our genetically confirmed SCA 3 patients.
This prospective single arm interventional study involved 13 genetically confirmed spinocerebellar ataxia (SCA) 3 patients with no concomitant diabetes, over 6 months. Following baseline assessment, patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily. Assessments were performed at baseline, 2, 4 and 6 months using ataxia rating scales (SARA, SCAFI and INAS) and EQ-5D-3L scale for quality of life assessment.
295 studies on the registry are indexed under Ataxia; 51 are open to participants now.
This study's enrollment of 13 is below the median of 26 across 216 interventional studies indexed under Ataxia.
Browse Ataxia studies →National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
supplement: trehalose
Dietary Supplement: trehalose
patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily
scale of rating of ataxia (SARA) score months,
Assessment of SARA scores by a single assessor
Time frame: 2 monthly intervals for 6 months
SCA Functional Index Scores
Assessment of SCAFI by a single assessor
Time frame: 2 monthly intervals for 6 months
EQ5D3L - quality of life scores
Assessment of quality of life scores
Time frame: 2 monthly intervals for 6 months
Side effects Profile
Adverse Effects
Time frame: 2 monthly intervals for 6 months
Blood investigation
Measurement of renal profile, fasting blood glucose, full blood count and liver profile
Time frame: At baseline and at 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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National University of Malaysia